Lyophilisate and suspension for suspension for injection.

Lyophilisate: White color.

Suspension: Opalescent liquid.

Per dose of 1 ml:

Active substances:

Live Feline Calicivirus (strain F9) 104.6 -106.1 CCID50*

Live Feline Viral Rhinotracheitis virus (strain F2) 105.0 -106.6 CCID50*

Live Feline Panleucopaenia virus (strain LR 72) 103.7 -104.5 CCID50*

* Cell Culture Infectious Dose

Active substance:

Minimum quantity of purified p45 FeLV-envelope antigen 102 μg

Adjuvants:

3% aluminium hydroxide gel expressed as mg Al3+ 1 mg

Purified extract of Quillaja saponaria 10 μg

Cats

For active immunisation of cats from eight weeks of age against:

Onset of immunity demonstrated from:

After the primary vaccination course, the duration of immunity lasts for one year for all components.

Following a first booster vaccination one year after the primary vaccination course, a duration of immunity of 3 years has been demonstrated for the leukaemia component.

Subcutaneous use.

Reconstitute one dose of lyophilisate with one dose of solvent, shake gently and administer immediately.

Administer subcutaneously one dose (1ml) of the veterinary medicinal product according to the following regimen of vaccination.

Maternally derived antibodies, especially those against feline panleucopenia virus, can negatively influence the immune response to vaccination. In such cases where maternally derived antibodies are expected, a third injection may be appropriate from 15 weeks of age.

Following a first booster vaccination one year after the primary vaccination course, subsequent vaccinations can be performed at intervals of three years for the leukaemia component.

In this case, since annual revaccination is required for calcivirus, rhinotracheitis virus and panleucopenia virus components, a single dose of Feligen RCP can be used annually.

This vaccine can be used as a booster for kittens or cats previously vaccinated with FELIGEN RCP and LEUCOGEN separately.

None

Vaccinate healthy animals only

Maternally derived antibodies, especially those against feline panleucopenia virus, can negatively influence the immune response to vaccination.

De-worming at least 10 days prior to vaccination is recommended.

Only feline leukaemia virus (FeLV) negative cats should be vaccinated. Therefore, a test for presence of FeLV before vaccination is recommended.

The feline calicivirus and feline panleucopenia virus vaccine strains can spread. It has been demonstrated that this spread did not cause adverse reactions on non-vaccinated cats.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

A moderate and transient local reaction (≤2 cm) is commonly observed after the first injection. This local reaction could be a swelling, an oedema or a nodule and resolves spontaneously within from 3 to 4 weeks at the most. After the second injection, and subsequent administrations, this reaction is markedly reduced.

The transient signs following vaccination such as hyperthermia (lasting 1 to 4 days), apathy and digestive disturbances may also be commonly observed.

Pain at palpation, sneezing or conjunctivitis may be noted in rare cases. This resolves without any treatment.

Anaphylactic reactions have been reported in very rare cases. In case of anaphylactic shock, appropriate symptomatic treatment should be administered.

Febrile limping syndrome reactions may occur very rarely in kittens, as reported in the literature after the use of any vaccine containing a Feline Calicivirus component.

Do not use in pregnant cats.

Use is not recommended during lactation.

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

No adverse reactions were observed after an overdose administration (10 doses of lyophilisate and 2 doses of suspension) of the veterinary medicinal product other than those mentioned in section 4.6 except local reactions that can last longer (from 5 to 6 weeks at the most).

Not applicable.

Gelatin, Potassium hydroxide, Lactose monohydrate, Glutamic acid, Potassium dihydrogen phosphate, Dipotassium phosphate, Water for injections, Sodium chloride, Disodium phosphate anhydrous

Sodium chloride, Disodium phosphate anhydrous, Potassium dihydrogen phosphate, Aluminium hydroxide gel, Quillaja saponaria, Water for injections

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Shelf life of the veterinary medicinal product as packaged for sale: 2 years.

Shelf life after reconstitution: use immediately.

Store and transport refrigerated (2 °C – 8 °C).

Do not freeze.

Protect from light.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Plastic or cardboard box of 10 lyophilisate vials and 10 suspension vials.

Plastic or cardboard box of 50 lyophilisate vials and 50 suspension vials.

Not all pack sizes may be marketed.

Immunological properties

Pharmacotherapeutic group: immunologicals for Felidae, live and inactivated viral vaccines for cats.

ATCvet code: QI06AH07.

Vaccine against feline viral rhinotracheitis, feline calicivirosis, feline panleucopenia and feline leukaemia.

The vaccine contains the purified p45 FeLV-envelope antigen, obtained by genetic recombination of the E. coli strain. The antigenic suspension is adjuvanted with an aluminium hydroxide gel and with a purified extract of Quillaja saponaria.

For the leukaemia component, protection against persistent viraemia is observed in 73% of cats 3 weeks after their first vaccine injection.

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